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临床试验/NCT03966027
NCT03966027招募中不适用

Immediate Vs. Delayed Weight Bearing Postoperative Protocol in Diabetic Ankle Fractures

Kyle Schweser MD1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2020年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
25
试验地点
1
主要终点
Adverse Events

研究概览

简要总结

Operatively managed diabetic ankle fractures have significant risk for complications. The cause for failure is likely multifactorial, however, a component of failure has to do with an inability to process pain and pressure normally. This loss of protective sensation allows for an increase in abnormal stresses placed on the recently repaired fractures. Historically, diabetics have been kept non weight bearing for extended periods of time, which has its own functional and cardiovascular issues. The purpose of the study is to determine if a protocol of immediate weight bearing with a hindfoot offloading brace after surgically corrected ankle fracture in a diabetic patient will maintain adequate motion, have no difference in complications when compared to regular non-immediate weight bearing protocols, and lead to good outcome scores and patient satisfaction scores

详细描述

Operatively managed diabetic ankle fractures have significant risk for complications. The cause for failure is likely multifactorial, however, a component of failure has to do with an inability to process pain and pressure normally. This loss of protective sensation allows for an increase in abnormal stresses placed on the recently repaired fractures. Historically, diabetics have been kept non weight bearing for extended periods of time, which has its own functional and cardiovascular issues. The purpose of the study is to determine if a protocol of immediate weight bearing with a hindfoot offloading brace after surgically corrected ankle fracture in a diabetic patient will maintain adequate motion, have no difference in complications when compared to regular non-immediate weight bearing protocols, and lead to good outcome scores and patient satisfaction scores

Patients will be recruited from the trauma and foot & ankle service lines. Patients who have experienced an isolated ankle fracture (excluding pilon fracture) and will undergo operative fixation within 3 weeks of injury will be approached for consent. Patients will then be screened based on the inclusion and exclusion criteria. Up to 25 patients will be enrolled

The following protocol will be applied after enrollment

  1. Pre-operatively

a. Hemoglobin A1c will also be collected from each patient if it has not been performed within the last 30 days. 2. Post-operatively a. Post-surgery i. Standard of Care:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults 18 and ove
  • •Positive for diabetes
  • •Positive monofilament test
  • •Isolated ankle fracture (non-pilon) and undergoing operative intervention within 3 weeks of fracture
  • •Weight less than 275 (124kg)
  • •Can tolerate and comply with brace
  • •No signs of pre-existing charcot arthroplasty or ankle deformity

排除标准

  • •Pregnant patients
  • •No signs of diabetes complicated by neuropathy
  • •Non-operative ankle fractures
  • •Multiple extremity injury
  • •Cannot follow post-operative protocol
  • •Chronic ankle fractures receiving surgery beyond 3 weeks of injury

研究组 & 干预措施

Hindfoot Offloading Braces / Immediate Weight-bearing

Experimental

Diabetic patients over 18 years of age who sustained an isolated (non-pilon) ankle fracture will undergo ORIF of the ankle fracture within 3 weeks of the event

干预措施: Postoperative protocol (Immediate weight bearing) (Other)

No Hindfoot Offloading Braces / Delayed Weight-Bearing

Placebo Comparator

Diabetic patients over 18 years of age who sustained an isolated (non-pilon) ankle fracture will undergo ORIF of the ankle fracture within 3 weeks of the event

干预措施: Postoperative Protocol (Delayed Weight Bearing) (Other)

结局指标

主要结局

Adverse Events

时间窗: 12 months

Adverse Events by type over time, severity, seriousness, and relatedness. AEs will be tabulated and summarized as counts and percentages. AEs will also be cross-tabulated according to: 1. Severity; 2. Unanticipated Adverse Device Effect (UADE) 3. Seriousness (Serious Adverse Event (SAE), Non-serious AE); 4. Device-Relatedness (Unrelated, Possibly Related, Probably Related, Definitely Related); 5. Procedure-Relatedness (Unrelated, Possibly Related, Probably Related, Definitely Related).

次要结局

  • AAOS Foot and Ankle Score(12 Months)
  • PROMIS Score(12 Months)

研究者

发起方
Kyle Schweser MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kyle Schweser MD

Assistant Professor Orthopaedic Trauma/Foot and Ankle

University of Missouri-Columbia

研究点 (1)

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